Epidemiological Study on the Surgical Removal of Third Molars

NCT02481700 | Completed

• 1 other identifier: S57824
• Study Type: observational
• Target: 6,010
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to get a clear view on current practice of surgical third molar removal in Belgium and the association with morbidity and complications. For this prospective cohort study, patients who visit the outpatient department of Oral and Maxillofacial Surgery of the University Hospitals Leuven or hospitals affiliated with the Flemish Hospital Network will be participating. All included patients are referred from primary dental providers for the surgical removal of one or more third molars. Before participating, written informed consent will be recorded from all eligible subjects. Patients consult one of the oral and maxillofacial surgeons or residents working on the department of the University Hospitals Leuven for the removal of third molars. In the standard procedure, patients are not routinely clinically monitored after one week at the department. Pre-operative, operative and postoperative data will be collected through a questionnaire, extracted data from the patient's medical file and panoramic radiography. The surgeon's individual operation technique will be registered through a one-off questionnaire. The questionnaires are taken at the same time of consultation and includes a maximum of 8 questions per time and are considered as non-invasive and a minimal burden for the patient. Postoperatively, patients record their recovery status and ability to resume daily- and work activities at day 3 and 10 by using a dairy system and, if necessary, revisit the outpatient department of oral and maxillofacial surgery.

Conditions

Impacted Third Molar Tooth

Outcome Measures

Primary Outcomes (1)

• Morbidity

  Assessing pain, trismus, swelling and neurosensory disturbances

  10 days

Secondary Outcomes (1)

• Resuming daily activities

  10 days

Interventions

Third molar removal PROCEDURE

The surgical removal of third molars

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All included patients are referred from primary dental providers for the surgical removal of one or more third molars

You may qualify if:

• referred for the removal of one or more third molars

You may not qualify if:

• other concomitant oral procedures in the same surgical session

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2015
• First Posted: June 25, 2015
• Study Start: September 10, 2015
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: October 8, 2020

Record last verified: 2020-10